Reversible Prevention of Pregnancy
Conditions
Brief summary
This study aims to evaluate the safety and efficacy of the IUB SCu300A spherical copper IUD compared to the standard T shaped copper IUD, the TCu380. Participants will be followed for one year and quality of life measurements will be measured during this period as well.
Interventions
DEVICESCu300A IUB
Spherical copper contraceptive
DEVICETCu380A IUD
T-shaped copper IUD
Sponsors
Ocon Medical Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 42 Years
Healthy volunteers
Yes
Inclusion criteria
\* Adult females aged 25-42 * Free and willing to fully comply with treatment process * Healthy women seeking LARC * Married or in a steady relationship (at least 1 year) * Blood hemoglobin \>11.5gr% * Signed informed consent form * If took COCP at least had one cycle after use of OC
Exclusion criteria
(major) * Use IUB/IUD as an emergency contraception * A previously placed IUD that has not been removed * Pregnancy or suspicion of pregnancy * Use of other contraception method (condom for either male or female, oral contraceptives, diaphragms, spermicides, hormonal patches, injections or ring, cervical cap) * History of pelvic inflammatory disease, recent or remote. * Postpartum endometritis or post abortal endometritis in the past 3 month * Mucopurulent cervicitis * Endometrial thickness more than 12 mm on insertion date * Known anemia * History of previous IUD complications * Dysfunctional uterine bleeding * Undiagnosed uterine bleeding * Malignancy or suspected malignant disease of female inner or outer genitalia * Distortions of the uterine cavity by uterine fibroids or known anatomical abnormalities * Known intolerance or allergy to nitinol or copper and/or copper IUDs - Wilson's disease. * Medication that may interfere with the subject's ability to complete the protocol * Use of injectable contraception in the previous year * Any other significant disease or condition that could interfere with the subject's ability to complete the protocol * A history of alcohol or drug abuse * Known infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C * Pregnancy or pregnancy planned during the year * Enrollment (less than 30 days after completing another study) in or planned to be enrolled in another study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perforation rate | During device insertion | Number of subjects with partial or complete perforation through the uterine wall |
| Device expulsion | 12 months | Number of subjects with partially or fully ejected devices |
| Efficacy in preventing pregnancy | 12 months | Number of women who become pregnant during the trial period. |
| Device malposition | 12 months | Number of subjects with observed device malposition within the uterine cavity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menorrhagia and dysmenorrhea rates | 12 months | Recording of menstrual pain, cramps and irregular bleeding as reported by subjects. |
Countries
Israel
Outcome results
None listed